Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury

Biological/cell based
General health
Online since 3 November 2021, updated 839 days ago

About this trial

This trial is recruiting individuals with acute thoracic (chest area) spinal cord injuries to test the safety and effect of a stem cell application. Stem cells have been reported in animal studies to limit secondary cell damage and promote nerve regeneration. This study investigates the use of adipose (fat)-derived (mesenchymal) stems cells. Decompression and stabilization surgery (DSS) of the spinal column is routinely performed after SCI, and it is at this time the stem cells (derived from fat cells) can also be injected into the injured spinal cord. The study has two focuses: cell injection versus a control group (no cells), and a lower dose of cells versus a higher dose. If selected participants will undergo routine DSS within 5 days after SCI. Participants will then either receive the stem cell injection or no stem cell injection; neither participant nor investigator will know the treatment administered. In the follow-up period, participants will undergo neurological testing for any changes in sensory and motor function.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T1 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 24 hours
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    T1-T12
    Additionally, participants must
    have a spinal cord injury for less than 5 days (24-120h) when the surgery and treatment occurs.
    have a neurological level of injury between T1 and T12.
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Biological/cell based

    Details

    A single-dose injection of the stem cell treatment into the injury site. Follow-up neurological testing for 1 year.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Dec 2016
    • Organisation
    • Ferrer Internacional S.A.
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Dec 2016
    • Organisation
    • Ferrer Internacional S.A.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more